Vancouver, Kelowna and Delta, British Columbia–(Newsfile Corp. – June 3, 2024) – Investorideas. com, a benchmark investment platform, publishes the first in a two-part series on advances in medical devices for blood purification. with Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutics company whose goal is to treat cancer and life-threatening infectious diseases.
Read the full article on Investorideas. comhttps://www. investorideas. com/News/2024/biotech/06030Blood-Purification-Medical-Devices. asp
According to Straits Research, “the global blood purification apparatus market length is valued at $17,755. 6 million in 2021. It is expected to reach $29,242. 21 million by 2030. “
Aethlon Medical, Inc. (NASDAQ: AEMD), with a long history of developing its proprietary Hemopurifier® blood purification device, today released an update on its planned Phase 1 clinical trials on the safety, feasibility, and dosage studies of its Hemopurifier®. in patients with malignant tumors treated with solid or progressive disease with anti-PD-1 monotherapy, such as Keytruda® or Opdivo®.
“We continue to make progress in preparing for our planned oncology trials on safety, feasibility, and ‘dose finding’ in Australia and India, and we would like to provide our shareholders and other stakeholders with an update,” said Steven LaRosa, MD. Chief Medical Officer of Aethlon Medical. ” In early May, we announced new insights into the in vitro removal of exosomes from cancer patients’ plasma in a miniature edition of our Hemopurifier®. This knowledge was temporarily incorporated into the documentation required for ethics forums at our prospective clinical sites. On May 17, 2024, we provided those documents to contract study organizations for those planned clinical trials. Subsequently, on May 24, 2024, a potential site submitted the documents to its ethics committee. Another site in Australia and a few others in India are in the process of being set up. The dossiers will be submitted to their ethics committees.
“Once we obtain the expected approvals from the ethics committee, we will finalize the agreements on the clinical trials. After that, hospitals will be able to start recruiting patients for trials. “
As a reminder, the target patient population of these safety, feasibility, and dose-finding trials are cancer patients with sham tumors who have failed their treatment with anti-PD-1 monotherapy, such as Keytruda® or Opdivo®.
The Aethlon Hemopurifier® is a first-class generation designed for the immediate depletion of circulating cancer-promoting exosomes and viruses. The U. S. Food and Drug AdministrationThe U. S. Food and Drug Administration (FDA) has designated the Hemopurifier® as an “innovative device” for the treatment of people with complex or metastatic cancer who do not respond to or tolerate popular therapy and who have cancers in which exosomes have been shown to be involved in disease progression or severity; and life-threatening viruses that are not treated with approved therapies.
Zach’s Research recently commented on Aethlon following positive results from an in vitro binding study he had implemented on Hemopurifier’s® potential to remove extracellular vesicles (EVs) from the plasma of cancer patients.
“Knowledge from this in vitro study is a critical detail for the Company to move Hemopurifier forward in oncology clinical studies toward potential regulatory approval and commercialization. The Company then intends to upload that knowledge into its Clinical Investigator Brochure, which will then be submitted. Ethics forums of clinical sites interested in the planned Phase 1 oncology trials in Australia and India. We expect the AEMD to present the Clinical Investigator’s Brochure this month.
“The AEMD will then seek approval from the respective ethics committees of the interested sites in India. The company has a strong clinical relationship with Medanta Medicity Hospital in Delhi, India, which is currently in a hemopurifier study in COVID patients and we are not surprised if Medanta Medicity Hospital had interest in the oncology study.
“Depending on how long it will take for sites to review and potentially approve participation in the Phase 1 trial of Aethlon, our clinical efforts could begin in the second half of 24. Whether Aethlon can demonstrate Hemopurifier’s ability to improve outcomes for cancer patients. of other cancers, we anticipate strong advertising customers for Hemopurify. “
In early May, CytoSorbents Corporation, a pioneer in blood purification technologies in critical care and cardiac surgery, announced its unaudited monetary and operating effects for the quarter ended March 31, 2024. The company reported a 14% year-over-year increase in product sales and a sequential quarterly growth of 22%.
From the News: Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, said: “We are pleased to report a strong start to 2024, driven by significant sales expansion and operational efficiencies. Product sales in the first quarter of 2024 were $9. 0 million, marking the highest quarter for CytoSorb’s core sales in just about 3 years. We increased our product’s gross margin to 76%, excluding non-recurring stock adjustments, an absolute increase of 8% from the first quarter of 2023, highlighting scalability and power. of our health. State-of-the-art production facilities and processes.
In addition, lead investigator Dr. Michael Mack presented the effects of the pivotal STAR-T (safe and timely antithrombotic removal of ticagrelor) randomized controlled trial in the U. S. and Canada. He is a member of the U. S. and Canadian at the American Association for Thoracic Surgery (AATS) and the KOL Annual Meeting. and the Investor/Analyst Day we hosted earlier this week (replay available) in which we supported a favorable benefit-threat profile of the DrugSorb-ATR system* on perioperative bleeding risk in patients undergoing remote coronary artery bypass graft (CABG). 2 days after receiving Brilinta® (ticagrelor, AstraZeneca). We have garnered positive and encouraging feedback about the importance of this knowledge and the unmet medical need of cardiothoracic surgeons. Going forward, we expect to submit marketing programs for DrugSorb-ATR, which has an FDA Breakthrough Device designation, to the FDA under the De Novo pathway and to Health Canada in the third quarter of 2024. “
Also focused on blood purification, Cerus Corporation, committed solely to safeguarding the world’s blood supply, announced its monetary effects for the first quarter ended March 31, 2024.
Highlights included:
The company reiterates its full-year 2024 earnings direction diversity of $172 million to $175 million. This diversity includes the full-year 2024 direction for the INTERCEPT Fibrinogen Complex, which is expected to be between $8 million and $10 million.
“The Cerus team delivered on our plans for the first quarter, paving the way for the remainder of 2024, with wonderful progress on clinical milestones and a strong return to expansion in our advertising business. The positive effects of ReCePI, the US Phase 3″The INTERCEPT red blood cell clinical trial is a vital milestone for the program and for our efforts to potentially advertise this product globally,” said William “Obi” Greenman, president and chief executive officer of Cerus. “Red blood cells are the maximum transfused blood parts worldwide, and we are committed to offering our consumers worldwide the full diversity of INTERCEPT for all transfused blood parts.
The INTERCEPT Blood System for Platelets and Plasma is available internationally and remains the only pathogen relief formula with CE marking and FDA approval for any of the blood components. The INTERCEPT red blood cell system is recently under regulatory review in Europe and at an advanced stage. Also in the United States, the INTERCEPT cryoprecipitation blood system is approved for the production of pathogen-reduced cryoprecipitate fibrinogen complex (commonly known as INTERCEPT fibrinogen complex), a curative product for the treatment and control of related bleeding. with fibrinogen deficiency, adding heavy bleeding.
In mid-May, Spectral Medical Inc. , a Phase 3 company seeking approval from the U. S. FDA, announced that the U. S. Department of Homeland Security (FDA) would announce that the U. S. Department of Homeland Security (FDA) would not be able to obtain a Phase 3 grant to the U. S. Food and Drug Administration (FDA). The U. S. Department of Homeland Security announced its financial effects for the first quarter ended March 31, 2024, and provided a corporate update.
PMX is a curative hemoperfusion device that removes endotoxins that can cause sepsis from the bloodstream and is guided through the company’s Endotoxin Activity Test (EAA), the only FDA-approved diagnosis for the threat of sepsis.
News Excerpt: Spectral continued its significant progress during the first quarter of 2024, both clinically and operationally, and since the beginning of the year, 25 patients have been enrolled for a total of 106 patients over the overall goal of 150 patients. The company is focused on maximizing efforts to enroll and complete the Tigris trial and believes the continued addition of new Tigris sites beginning in the fourth quarter of 2023 could further drive enrollment and allow Spectral to temporarily reach the 150-patient goal. , which would bring the company closer to submission and possible FDA approval. In addition to its clinical trials, the company continues to work intensively with its advertising partner, Baxter. In the first quarter of 2024, Baxter exercised its right to maintain its exclusive distribution of PMX products in the United States and Canada and paid Spectral a non-dilutive milestone payment. Additionally, Spectral and Baxter mutually agreed to replace the initial duration of their advertising partnership to ten years following FDA approval of PMX. The Company believes that this amendment provides the parties with a mutually favorable avenue to maximize PMX advertising economics, while providing motivation for continued support and resource allocation to the PMX association.
The blood purification generation made headlines during the pandemic when several companies, including Baxter International Inc. , obtained Emergency Use Authorization (EUA) from the U. S. FDA. Baxter UU. La s approval was for the company’s Oxiris product intended to treat patients who have shown COVID-19 and have been admitted to the intensive care unit (ICU) with overt or near respiratory failure requiring blood-purifying treatment to decrease levels of pro-inflammatory cytokines. Use in continuous renal replacement therapy (CRRT) is added.
Regardless of its existence in cancer treatment, Aethlon (NASDAQ: AEMD) is investigating the possibility of using Hemopurifier® in viral diseases under an open investigational device (IDE) waiver and its groundbreaking FDA designation for “. . . Life-threatening glycosylated viruses that are not treated with an approved treatment.
Based on our studies so far, Hemopurifier has potential for many pathogenic viruses in humans, including HCV, HIV, Sars-CoV-2, and Ebola. “
For corporations in this sector, the drive to innovate is “in their blood,” and with the global threats of long-term viruses and pandemics, it’s an industry worth watching.
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